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Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence (ADVICE)

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Marketed experience application on adherence

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Post-market study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient's written informed consent obtained prior to any study-related procedures
Male or female patient aged 18 years and above
Patient with established diagnosis of asthma for at least 6 months
Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS
Patient with ACT score <20 at screening and at randomization
Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening
Patient must have their own Android® or iPhone operating system (IOS) smartphone
Ability to use the pMDI device correctly

Exclusion Criteria:

Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening
Patient with a history of near-fatal asthma
Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis
Patient not able to be compliant with the study requirements.
Patient with a BMI > 40
Patient working on night shifts
Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening.
Patient who has an already planned major surgery or hospitalization
Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months.
Patient with a history of hypersensitivity to any of the components of Foster pMDI

Sites / Locations

Barlow Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Reference

Intervention

Arm Description

Control experience using marketed application to record medication intake without reminders from the app

Full experience using marketed application, with all functionalities enabled

Outcomes

Primary Outcome Measures

Change from Baseline in adherence rate to entire treatment period

Adherence Rate of doses correctly taken twice daily

Secondary Outcome Measures

Full Information

NCT ID

NCT03951714

First Posted

May 14, 2019

Last Updated

June 28, 2021

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT03951714

Brief Title

Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence

Acronym

ADVICE

Official Title

12-wks Randomised Controlled Trial to Explore the Effect of a Smartphone App. Connected to an Add-on Device System Fitted on pMDI Inhaler on Adherence to Medications Intake and Clinical Outcomes in Difficult-to-treat Asthmatic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

August 12, 2019 (Actual)

Primary Completion Date

July 6, 2020 (Actual)

Study Completion Date

July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Post-market study

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reference

Arm Type

Other

Arm Description

Control experience using marketed application to record medication intake without reminders from the app

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Full experience using marketed application, with all functionalities enabled

Intervention Type

Behavioral

Intervention Name(s)

Marketed experience application on adherence

Intervention Description

To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence

Primary Outcome Measure Information:

Title

Change from Baseline in adherence rate to entire treatment period

Description

Adherence Rate of doses correctly taken twice daily

Time Frame

From baseline to end of participation (up to 3 months)

Other Pre-specified Outcome Measures:

Title

Asthma Control Test score

Description

Change from Baseline

Time Frame

From baseline to end of participation (up to 3 months)

Title

Test of the Adherence to Inhalers score

Description

Change from Baseline

Time Frame

From baseline to end of participation (up to 3 months)

Title

Percentage of days without intake of rescue medication

Description

Change from Baseline

Time Frame

From baseline to end of participation (up to 3 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient's written informed consent obtained prior to any study-related procedures Male or female patient aged 18 years and above Patient with established diagnosis of asthma for at least 6 months Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS Patient with ACT score <20 at screening and at randomization Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening Patient must have their own Android® or iPhone operating system (IOS) smartphone Ability to use the pMDI device correctly Exclusion Criteria: Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening Patient with a history of near-fatal asthma Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis Patient not able to be compliant with the study requirements. Patient with a BMI > 40 Patient working on night shifts Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening. Patient who has an already planned major surgery or hospitalization Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months. Patient with a history of hypersensitivity to any of the components of Foster pMDI

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annaliese Linnhoff

Organizational Affiliation

Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barlow Medical Centre

City

Manchester

ZIP/Postal Code

M20 2RN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35691614

Citation

Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

Results Reference

derived

Links:

URL

https://www.chiesi.com/en/chiesi-clinical-study-register/

Description

Structured Summary Data Results on Chiesi Clinical Study Register

Learn more about this trial

Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence

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